Roche launches CoaguChek Pro II system to determine coagulation status of patients at all points of care

Basel, Switzerland

November 25, 2015

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has launched the CoaguChek Pro II system in countries accepting the CE Mark1. CoaguChek Pro II combines two tests in a single device - the activated partial thromboplastin time (aPTT) test and the prothrombin time (PT) test with extended claims - for greater insight into patients’ coagulation status in acute care settings, such as emergency rooms, operating rooms and intensive care units, or anticoagulation clinics.

CoaguChek Pro II can be used to identify the presence of vitamin K antagonists in patients with acute bleeding or to detect possible coagulation factor deficiency. It can also be used to monitor the real time anticoagulant effect in patients treated with unfractionated heparin.

CoaguChek Pro II provides results without having to spend valuable time waiting for lab results. Instead, ER staff can run the test on the handheld device next to the patient2.

Transferring critical information when and where it is needed is possible with built-in WIFI connectivity. Test results can be automatically transmitted in real time from the device to patients’ electronic health records, ensuring that vital information is immediately available at every point of care. Furthermore, it eliminates transcription steps, thereby streamlining workflow and reducing the possibility of human error.

CoaguChek Pro II also has a first-in-market QR code feature. Test results can be transformed into a QR code and transferred, for example via mobile phone. This can be valuable in remote settings, allowing a visiting nurse to measure coagulation values for a homebound patient, and send the result using cellular data to a doctor. Based on the result, the physician can provide a new anticoagulant dosing schedule in real time - all while the nurse remains with the patient.

Building on the best in class quality, CoaguChek Pro II is small, light and convenient with accuracy and precision that our customers have come to expect from CoaguChek® over the past 20 years, said Jean-Claude Gottraux, Head of Roche Professional Diagnostics. As the latest addition to the CoaguChek family, CoaguChek Pro II expands our coagulation point of care offering beyond self-monitoring and doctors’ offices to also include more specialized settings such as the ER and OR.

More about CoaguChek Pro II

The CoaguChek Pro II system is versatile, and easy to operate. Institution-wide implementation is easy thanks to seamless connections to existing Roche point of care IT solutions. The device is small and portable, requiring only a small sample volume of 8μl to run a full test, and accepts different blood sample types, including capillary blood from a finger prick as well as venous and arterial whole blood. Accuracy and precision of the test strips is guaranteed since each lot of the test strips is pre-calibrated against the WHO reference method.

More about anticoagulant therapy

Millions of people worldwide are taking vitamin K antagonists (VKAs) for a variety of indications or conditions, such as atrial fibrillation (AF), deep vein thrombosis (DVT), pulmonary embolism (PE), and the presence of a mechanical heart valve (MHV). To best monitor the efficacy of VKAs, the prothrombin time PT (INR) needs to be frequently measured. This test can be performed at the point of care, using a small drop of blood from a patient’s fingertip.

More about CoaguChek

Taking the correct dose is crucial for efficient anticoagulation treatment. The correct dose is established by measuring how long it takes blood to clot, and is called the International Normalized Ratio (INR). The percentage of time INR values fall within the upper and lower target value is called Time in Therapeutic Range, or TTR. This is important because the more time patients are in range, the less chance of complications, such as blood clots of excessive bleeding.

Since 1993, CoaguChek systems from Roche have set the standard in INR testing for patients on oral anticoagulant therapy – whether through self-testing or point of care measurement by physicians. Every single day about 245,000 CoaguChek Strips are used around the world, with more than one million patients using CoaguChek XS since 2006.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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Local product availability may vary independently from CE Mark approval.

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